Suppliers and packagers for MANNITOL 10%

MANNITOL 10%

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	MANNITOL 10%	mannitol	INJECTABLE;INJECTION	016269	NDA	Henry Schein, Inc.	0404-9905-50	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE	2022-01-12
Hospira	MANNITOL 10%	mannitol	INJECTABLE;INJECTION	016269	NDA	Hospira, Inc.	0409-4031-01	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)	2004-11-30
Hospira	MANNITOL 10%	mannitol	INJECTABLE;INJECTION	016269	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1468-1	50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1)	2019-12-13

Suppliers for the Pharmaceutical Drug: Mannitol 10%

Last updated: August 9, 2025

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Introduction

Mannitol 10% is a hyperosmotic agent widely used in medical, pharmaceutical, and surgical applications. It functions primarily as a diuretic, osmoregulator, and neuroprotective agent in cases of increased intracranial pressure, cerebral edema, and renal function management. Given its vital clinical applications, a robust supply chain of pharmaceutical-grade Mannitol 10% is essential. This article evaluates key suppliers, their manufacturing capacities, regulatory compliance, and market positioning to inform procurement and investment decisions for healthcare institutions and pharmaceutical players.

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Global Manufacturers and Suppliers of Mannitol 10%

1. Merck KGaA (Sigma-Aldrich)

Overview: Merck KGaA, through its subsidiary Sigma-Aldrich, is a prominent provider of pharmaceutical excipients, including Mannitol. Their pharmaceutical-grade Mannitol conforms to USP, EP, and JP standards, ensuring safety and efficacy.

Supply Capabilities: With extensive manufacturing facilities across Europe and North America, Merck can supply large volumes of Mannitol 10%. The company's strong distribution network ensures worldwide reach, including North America, Europe, and Asia.

Regulatory Compliance: Merck’s Mannitol products are certified with rigorous adherence to quality standards, including ISO certifications, and are approved by major health authorities like the FDA and EMA.

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2. Roquette Frères

Overview: A leading global player in specialty ingredients, Roquette supplies Mannitol for pharmaceutical and food industries. Their pharmaceutical-grade Mannitol meets specifications of pharmacopeias such as USP and EP.

Supply Capabilities: Roquette has a significant manufacturing presence in Europe, notably in France, with dedicated facilities for pharmaceutical excipients. They have the capacity to produce high-purity Mannitol at large scales.

Unique Attributes: Known for quality assurance and environmental sustainability practices, Roquette continues to expand its manufacturing base to meet increasing global demand.

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3. Fosfa A/S

Overview: Danish-based Fosfa specializes in the production of sweeteners and excipients, including Mannitol. They offer high-purity pharmaceutical-grade Mannitol suitable for injection, oral, and other medical applications.

Supply Capabilities: Fosfa maintains robust manufacturing capabilities primarily in Europe, with an emphasis on high-quality, reliable supply chains.

Regulatory Profile: Fosfa’s Mannitol complies with international pharmacopoeial standards and has received approvals from major regulatory authorities.

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4. Changzhou Goodscend Pharmaceutical Co., Ltd.

Overview: A China-based manufacturer that has grown significantly in the recent decade, offering pharmaceutical excipients including Mannitol. They cater mainly to the Asia-Pacific and emerging markets.

Supply Capabilities: Known for competitive pricing, Changzhou Goodscend has invested in expanding capacity to meet growing international demand, with a focus on quality.

Regulatory Status: Their products are compliant with CP, USP, and EP standards, and they are progressing towards gaining broader regulatory approvals including FDA registration.

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5. SPI Pharma

Overview: SPI Pharma supplies excipients, including Mannitol, primarily for use in formulation development across the pharmaceutical industry.

Supply Capabilities: Through their manufacturing facilities in North America and Europe, SPI Pharma can flexibly supply Mannitol for clinical and commercial applications at various scales.

Quality Standards: Their Mannitol products are manufactured under cGMP standards, and they regularly obtain regulatory clearances for pharmaceutical use.

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Regional Suppliers and Market Dynamics

Asia-Pacific: The region hosts numerous manufacturers such as Changzhou Goodscend and other smaller producers offering competitively priced Mannitol. While these suppliers provide excellent cost advantages, procurement from them often requires rigorous quality audits and regulatory validation.

Europe and North America: Suppliers like Merck and Roquette dominate the high-quality, regulatory-compliant segment, with extensive capacity, reliable delivery timelines, and comprehensive regulatory approvals.

Emerging Markets: Suppliers such as Fosfa and smaller Chinese manufacturers offer flexible and cost-effective options, yet they may require enhanced due diligence concerning quality control and regulatory compliance.

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Regulatory and Quality Considerations

Procurement of Mannitol 10% for pharmaceutical use mandates strict adherence to quality standards. Suppliers should provide certificates of analysis (CoA), Good Manufacturing Practice (GMP) compliance, and pharmacopeial conformance (USP, EP, JP). Regulatory approvals from authorities like the FDA, EMA, or equivalent bodies fortify supplier credibility.

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Supply Chain Challenges and Opportunities

• Supply Disruptions: Global supply chains are susceptible to disruptions due to geopolitical issues, pandemics, or raw material shortages. Diversifying suppliers across regions mitigates risks.

• Quality Assurance: The increasing stringency of regulatory standards necessitates suppliers' compliance with cGMP and high-purity manufacturing practices.

• Cost Optimization: Engaging with regional suppliers or developing local manufacturing partnerships can reduce costs and lead times.

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Conclusion

The selection of Mannitol 10% suppliers hinges on balancing quality, regulatory compliance, capacity, and cost. Major global suppliers like Merck KGaA and Roquette provide high-quality, compliant products suitable for critical pharmaceutical applications. Asian manufacturers offer cost-effective alternatives but require thorough vetting to ensure quality standards. Strategic sourcing, based on regulatory approval, supply reliability, and quality assurance, remains paramount.

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Key Takeaways

• Leading global suppliers such as Merck and Roquette dominate the high-standard pharmaceutical Mannitol market with established capacities and regulatory approvals.

• Regional and emerging market suppliers offer cost advantages but warrant comprehensive due diligence on quality and compliance.

• Regulatory adherence is critical; suppliers must provide certifications aligning with pharmacopeial standards (USP, EP, JP) and regulatory approvals for specific markets.

• Supply chain diversification mitigates risks associated with geopolitical disruptions, pandemics, or raw material shortages.

• Engaging with suppliers capable of scaling production and maintaining stringent quality controls ensures a reliable supply for critical medical applications.

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FAQs

1. What are the primary uses of Mannitol 10% in clinical settings?
Mannitol 10% is mainly used to reduce intracranial pressure, treat cerebral edema, and serve as a diuretic in patients with renal failure or during surgical procedures.

2. What qualities should healthcare providers consider when sourcing Mannitol 10%?
Regulatory compliance (FDA, EMA approvals), pharmacopeial standards (USP, EP), purity levels, GMP certification, and supply reliability.

3. Are there regional differences in Mannitol manufacturers?
Yes. Europe and North America host high-capacity, regulated producers, whereas Asia-Pacific suppliers often compete on cost but may vary in regulatory compliance.

4. How does regulatory approval impact supplier selection?
Regulatory approval assures adherence to quality and safety standards, reducing risk of contamination, substandard efficacy, or compliance issues in medical use.

5. What are the main challenges in sourcing Mannitol 10% globally?
Supply chain disruptions, regulatory hurdles, quality assurance, and balancing cost with supplier credibility.

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References

[1] Sigma-Aldrich official product listings and regulatory documentation.
[2] Roquette Frères corporate literature and product datasheets.
[3] Fosfa A/S regulatory and quality certifications.
[4] Changzhou Goodscend Pharmaceutical Co., Ltd. product registration data.
[5] SPI Pharma manufacturing and compliance standards.